22814 Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either: 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, http://www.fda.gov/cber/ 

guidelines.htm or http:// 

www.regulations.gov. 

Dated: April 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10046 Filed 4–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–D–0140] (formerly 

Docket No. FDA–2005D–0261) 

Guidance for Industry: Nucleic Acid 

Testing (NAT) for Human 

Immunodeficiency Virus Type 1 (HIV– 

1) and Hepatitis C Virus (HCV): 

Testing, Product Disposition, and 

Donor Deferral and Reentry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Nucleic Acid 

Testing (NAT) for Human 

Immunodeficiency Virus Type 1 (HIV– 

1) and Hepatitis C Virus (HCV): Testing, 

Product Disposition, and Donor Deferral 

and Reentry’’ dated May 2010. The 

guidance document provides 

recommendations to blood and plasma 

establishments, manufacturers, and 

testing laboratories that are 

implementing a licensed method for 

Human Immunodeficiency Virus Type 1 

(HIV–1) Nucleic Acid Test (NAT) and 

Hepatitis C Virus (HCV) NAT, on testing 

individual samples or pooled samples 

from donors of human blood and blood 

components for HIV–1 ribonucleic acid 

(RNA) and HCV RNA. This guidance 

also contains recommendations 

regarding product disposition and donor 

management based on the results of 

NAT and serologic testing for markers of 

HIV–1 and HCV infection on samples, 

collected at the time of donation, from 

donors of human blood and blood 

components. The guidance announced 

in this notice finalizes the draft 

guidance of the same title, dated July 

2005. This guidance also supersedes the 

recommendations for reentry of donors 

deferred because of anti-HIV–1 test 

results, HIV–1 p24 antigen test results, 

and anti-HCV test results that were 

provided in the FDA memoranda 

entitled ‘‘Revised Recommendations for 

the Prevention of Human 

Immunodeficiency Virus (HIV–1) 

Transmission by Blood and Blood 

Products,’’ April 23, 1992; ‘‘Revised 

Recommendations for Testing Whole 

Blood, Blood Components, Source 

Plasma and Source Leukocytes for 

Antibody to Hepatitis C Virus Encoded 

Antigen (Anti-HCV),’’ August 5, 1993; 

‘‘Recommendations for Donor Screening 

with a Licensed Test for HIV–1 

Antigen,’’ August 8, 1995. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic or written 

comments on the guidance. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Paul 

Levine, Center for Biologics Evaluation 

and Research (HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Nucleic Acid Testing (NAT) 

for Human Immunodeficiency Virus 

Type 1 (HIV–1) and Hepatitis C Virus 

(HCV): Testing, Product Disposition, 

and Donor Deferral and Reentry,’’ dated 

May 2010. The guidance document 

provides recommendations to blood and 

plasma establishments, manufacturers, 

and testing laboratories that are 

implementing a licensed method for 

Human Immunodeficiency Virus Type 1 

(HIV–1) Nucleic Acid Test (NAT) and 

Hepatitis C Virus (HCV) NAT, on testing 

individual samples or pooled samples 

from donors of human blood and blood 

components for HIV–1 ribonucleic acid 

(RNA) and HCV RNA. This guidance 

also contains recommendations 

regarding product disposition and donor 

management based on the results of 

NAT and serologic testing for markers of 

HIV–1 and HCV infection on samples, 

collected at the time of donation, from 

donors of human blood and blood 

components. The guidance announced 

in this notice finalizes the draft 

guidance of the same title, dated July 19, 

2005. This guidance also supersedes the 

recommendations for reentry of donors 

deferred because of anti-HIV–1 test 

results, HIV–1 p24 antigen test results, 

and anti-HCV test results that were 

provided in the FDA memoranda 

entitled, ‘‘Revised Recommendations for 

the Prevention of Human 

Immunodeficiency Virus (HIV–1) 

Transmission by Blood and Blood 

Products,’’ April 23, 1992; ‘‘Revised 

Recommendations for Testing Whole 

Blood, Blood Components, Source 

Plasma and Source Leukocytes for 

Antibody to Hepatitis C Virus Encoded 

Antigen (Anti-HCV),’’ August 5, 1993; 

‘‘Recommendations for Donor Screening 

with a Licensed Test for HIV–1 

Antigen,’’ August 8, 1995. 

In the Federal Register of July 27, 

2005 (70 FR 43439), FDA announced the 

availability of the draft guidance of the 

same title. FDA received several 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. The guidance 

announced in this notice finalizes the 

draft guidance dated July 2005. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 22815 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either: 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulations.gov. 

Dated: April 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10048 Filed 4–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0123] 

Impact of Dissolvable Tobacco Use on 

Public Health; Request for Comments 

Correction 

In notice document 2010–6216 

beginning on page 13556 in the issue of 

Monday, March 22, 2010, make the 

following correction: 

On page 13556 in the second column, 

the paragraph that begins with ‘‘DATES:’’ 

should read: ‘‘DATES: Submit written or 

electronic comments by September 20, 

2010.’’ 

[FR Doc. C1–2010–6216 Filed 4–29–10; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Public Health 

Research on Craniofacial 

Malformation, Funding Opportunity 

Announcement (FOA) DP 10–001, 

Initial Review 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 3:30 p.m.–5 p.m., May 17, 

2010 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Public Health Research on 

Craniofacial Malformation, FOA DP 10–001.’’ 

Contact Person for More Information: 

Michael Dalmat, Dr.P.H., Scientific Review 

Officer, National Center for Chronic Disease 

and Health Promotion, Office of the Director, 

Extramural Research Program Office, 4770 

Buford Highway, NE., Mailstop K–92, 

Atlanta, GA 30341, Telephone: (770) 488– 

6423, E-mail: MED1@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 26, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–10087 Filed 4–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Cooperative 

Agreement Program for the National 

Academic Centers of Excellence in 

Youth Violence Prevention (U01), 

Funding Opportunity Announcement 

(FOA) CE10–004, Initial Review 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the aforementioned meeting: 

Times and Dates: 8 a.m.–5 p.m., July 22, 

2010 (Closed). 8 a.m.–5 p.m., July 23, 2010 

(Closed). 

Place: Embassy Suites Atlanta—Buckhead, 

3285 Peachtree Road, NE., Atlanta, Georgia 

30305, Telephone: 404–261–7733. 

Status: The meetings will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5, 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Section 10(d) of Public Law 

92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Cooperative Agreement Program 

for the National Academic Centers of 

Excellence in Youth Violence Prevention 

(U01), FOA CE10–004.’’ 

Agenda items are subject to change as 

priorities dictate. 

Contact Person For More Information: J. 

Felix Rogers, PhD, M.P.H., NCIPC/ERPO, 

CDC, 4770 Buford Highway, NE., M/S F63, 

Atlanta, Georgia 30341–3724, Telephone 

(770) 488–4334. 

The Director, Management Analysis and 

Services Office has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: April 26, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–10171 Filed 4–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Developmental Brain Disorders II. 

Date: May 5, 2010. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Jay Joshi, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 5196, MSC 7846, Bethesda, MD 

20892, (301) 408–9135, joshij@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1